期刊
BRITISH JOURNAL OF PSYCHIATRY
卷 199, 期 6, 页码 501-507出版社
CAMBRIDGE UNIV PRESS
DOI: 10.1192/bjp.bp.111.093336
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资金
- Agency for Healthcare Research and Quality
- Aldolor
- Alkermes
- AstraZeneca
- Bristol-Myers Squibb
- Cephalon
- Cyberonics
- Dey Pharmaceuticals
- Eli Lilly
- GlaxoSmithKline
- Janssen Pharmaceutica
- MedAvante
- Merck
Background There is controversy about the implications of relatively small average drug-placebo differences observed in randomised controlled trials of antidepressant medications. Aims To investigate whether efficacy is better understood as a large effect in a subgroup of patients. Method The mixture model was used to identify patient subgroups (patients benefiting or not benefiting from treatment) to directly model the skewness of Montgomery-Asberg Depression Rating Scale (MADRS) scores at week 8. Results The MADRS scores improved by 15.9 points (95% CI 15.2-16.6) among patients who benefited from treatment. The proportion of patients who benefited from escitalopram and not from placebo treatment was 19.5%, corresponding to a number needed to treat of 5. Conclusions This model gave a considerably better fit to the data than the analysis of covariance model in which all patients were assumed to benefit from treatment. The small average antidepressant-placebo difference obscures a much larger effect in a clinically meaningful subgroup of patients.
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